Supplier Quality Engineer I

This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. The Quality Engineer I executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems in accordance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards.

Responsibilities

• Participate in cross-functional new product development teams with focus on product/service quality and Quality System compliance.
• Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC, and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Update/establish documented work instructions as needed.
• Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
• Monitor and report on performance metrics.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and facilities within the company on quality-related issues.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
• Perform quality system audits and provide guidance on corrective actions.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in Engineering.
• Minimum of 1 year of related experience (combined Manufacturing/Quality Engineering/Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience).
• Minimum of 1 year of experience working in an ISO certified environment.
• Experience with medical device or other regulated industries.

Preferred Qualifications

• ASQ Certification.
• Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
• Knowledge of TrackWise, Windchill PLM, Grand Avenue, or other similar systems.
• Experience with supplier controls, supplier audits, or supplier monitoring.
• Knowledge of ISO 13485.

Skills

• Analyzes and solves technical problems.
• Seeks input from experienced individuals to improve quality of deliverables.
• Partners with team members to complete assigned tasks on time and seeks feedback from others regarding ideas or suggestions.
• Documents status and results accurately and succinctly.
• Provides clear and accurate data regarding product and process measurables.
• Uses good judgment regarding how to proceed on assigned tasks, and when to alert others.
• Displays curiosity about technology, the industry, and competitive knowledge.
• Adapts to change.

Schedule

• Onsite in Eden Prairie, MN, Monday through Friday during core business hours (7 AM to 4 PM or 8 AM to 5 PM).
• Occasional early morning calls with the team in Germany.

Benefits

• Market-competitive pay.
• Extensive Paid Time Off and added holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long- and short-term disability coverage.
• 401(k) with a company match.
• Maternity and paternity leave.
• Additional add-on benefits/discounts for programs such as pet insurance.
• Tuition reimbursement and continuing education programs.
• Excellent opportunities for advancement in a stable, long-term career.

Pay

Onsite pay range for this opportunity is $80,000 to $95,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than the range listed. Pay rates are based on factors including local labor market costs, years of relevant experience, education, professional certifications, and foreign language fluency.